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Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial…

ClinicalTrials.gov IDNCT05702463

PhasePHASE1

Enrollment30

SponsorMontreal Heart Institute

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Platelet Aggregation, Type 2 Diabetes, Aspirin, Diabetes Mellitus, Type 2, Platelet Aggregation Inhibitors

About this study

Interventions

Drug: Aspirin 81Mg Ec Tab twice daily for 7 days — Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
Drug: Aspirin 40Mg Chew Tab twice daily for 7 days — Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
Drug: Aspirin 162 mg EC Tab once daily for 7 days — Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.

Primary outcomes

Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial. (1 year)
Describe the enrollment rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial. (1 year)
Describe the enrollment rate by the proportion of eligible participants who consent to evaluate the feasibility of a larger scale randomized controlled trial. (1 year)
Describe the retention rate to evaluate the feasibility of a larger scale randomized controlled trial. (1 year)
Among initial ASA non-responder participants, define the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA. (1 year)

Eligibility information

Inclusion Criteria: 1. Age ≥ 18 years; 2. Participant must be naïve to ASA, defined as absence of chronic treatment with ASA within the previous 3 months, and of any ASA use within the previous 2 weeks; 3. Type 2 diabetes, based on at least one of the following criteria: (5) * Chronic treatment with oral antihyperglycemic agents or insulin therapy; * Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h); * 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT); * A1C ≥ 6.5% (48 mmol/ml); 4. Willing to attend all study visits of both the run-in and randomized phases of the trial. Exclusion Criteria: 1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current; 2. Known hypersensitivity to ASA; 3. Patient requiring dialysis; 4. Severe hepatic insufficiency or ALT \> 3 x ULN; 5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract; 6. Bleeding diathesis; 7. Platelet count or hemoglobin levels outside of the normal reference range; 8. Planned major surgical procedure or dental procedure during the course of the study; 9. Chronic inflammatory disease requiring regular anti-inflammatory treatment; 10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; 11. Active cancer; 12. History of hematological malignancy or myelodysplasia; 13. Pregnant or lactating women;

Study locations

Montreal Heart Institute, Montreal, Quebec H1T 1C8 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.